POS0040-HPR PATIENT PERCEPTIONS OF IMPACT OF GLUCOCORTICOID THERAPY IN THE RHEUMATIC DISEASES: INTERNATIONAL DEVELOPMENT OF A TREATMENT-SPECIFIC PATIENT REPORTED OUTCOME MEASURE
Authors: S. Bridgewater, M.A. Shepherd, J. Dawson, P. Richards, C. Silverthorne, M. Ndosi, C. Almeida, R.J. Black, J.T.L. Cheah, E. Dures, N. Ghosh, E.A. Hoon, S. Lyne, I. Navarro-Millan, D. Pearce-Fisher, C. Ruediger, J. Tieu, K. Yip, S. Mackie, S. Goodman, C. Hill, J. Robson
Journal: Annals of the Rheumatic Diseases (2022)

<h3>Background</h3> Glucocorticoids (GCs) are a key treatment for inflammatory rheumatic diseases, but they cause a wide range of adverse side-effects which are of concern both to patients and clinicians. <h3>Objectives</h3> The objective of this study was to explore the impact of GC therapy on health-related quality of life (HRQoL) during treatment for rheumatic diseases, as a basis for development of a Patient-Reported Outcome Measure (PROM) to be used in clinical trials and practice. <h3>Methods</h3> Patients from the UK, USA and Australia who were treated with GCs in the last two years for a rheumatic condition were invited to take part in semi-structured qualitative interviews. Purposive sampling was used to include participants with a range of demographic and disease features. A steering committee of patient research partners, clinicians and methodologists devised an initial conceptual framework, which informed interview prompts and cues. Interviews were carried out by experienced qualitative researchers who encouraged participants to tell their stories and talk about the effects, both adverse and beneficial, of their experiences and perceptions of treatment with GCs, to identify salient physical and psychological symptoms and aspects of HRQoL. The interview data were organised using NVivo, and inductive analysis identified initial themes and domains. Candidate questionnaire items were developed and refined using cognitive interviewing, linguistic assessment, and input from patient research partners. <h3>Results</h3> Sixty semi-structured qualitative interviews were conducted (UK n=34, USA n=10, Australia n=16). Mean participant age was 58 years; 39 (66.1%) were female. Purposive sampling of participants provided a broad range of demographic features, GC dosages and inflammatory rheumatic conditions, with 27% having connective tissue disease, 25% inflammatory arthritis, 30% systemic vasculitis and 16% other rheumatic conditions. Initial domains were developed to identify key themes relating to treatment using GCs and their impact on HRQoL; see Figure 1. A long-list of 134 initial candidate questionnaire items was developed from the individual themes. These items were reviewed by a qualitative working group of patient research partners, researchers and clinicians to reduce duplication and ambiguity of items. The resulting 62 items were tested and refined by piloting with patient research partners, iterative rounds of cognitive interviews with patients with a range of rheumatic conditions from the UK, USA and Australia, and a linguistic translatability assessment, to define a draft questionnaire of 40 items. <h3>Conclusion</h3> This international qualitative study underpins the development of candidate items for a treatment-specific PROM for patients with rheumatic diseases. The draft questionnaire is currently being tested in an online large-scale survey to determine the final scale structure and measurement properties using Rasch analysis, factor analysis, test-retest, comparison with EQ5D, and known groups analysis. <h3>Disclosure of Interests</h3> Susan Bridgewater Grant/research support from: Vifor Pharma, Michael A Shepherd Grant/research support from: Vifor Pharma, Jill Dawson: None declared, Pamela Richards: None declared, Christine Silverthorne: None declared, Mwidimi Ndosi: None declared, Celia Almeida: None declared, Rachel J Black: None declared, Jonathan T.L. Cheah: None declared, Emma Dures: None declared, Nilasha Ghosh: None declared, Elizabeth A Hoon: None declared, Suellen Lyne: None declared, Iris Navarro-Millan Consultant of: Honorarium on Swedish Orpham Biovitrum (SOBI) advisory board 2021, Diyu Pearce-Fisher: None declared, Carlee Ruediger: None declared, Joanna Tieu: None declared, Kevin Yip: None declared, Sarah Mackie: None declared, Susan Goodman: None declared, Catherine Hill: None declared, Joanna Robson Speakers bureau: EULAR Symposium 2021 for Vifor Pharma, Consultant of: Honorarium for Vifor Pharma advisory board 2021, Grant/research support from: Vifor Pharma 2020-2022